None listed
Conditions
Brief summary
This study explores a new non-invasive phototherapy approach for Type 1 Diabetes, using pulsed infrared light modulated by crystallised mineral salts (Quantum Salt-Enhanced, or QSE method). The aim is to explore the potential impact on glycaemic regulation. Ten participants aged 10 to 40 years with confirmed T1D (duration >3 years) will receive daily 30-minute sessions over 21 days. Outcomes include changes in fasting glucose, HbA1c, and participant-reported glycaemic stability. The study is sponsored by Quantech Group Ltd and has been submitted to HDEC for ethics review in New Zealand.
Interventions
Participants will receive daily 30-minute sessions of Quantum Salt-Enhanced (QSE) phototherapy for 15 to 21 consecutive days, depending on individual tolerance and scheduling adherence. The intervention uses a non-invasive device (EndoQSE) that emits low-frequency pulsed infrared light in the range of 4.0 to 7.2 Hz, modulated through crystallised mineral salts—lithium chloride (LiCl), magnesium chloride (MgCl2), and zinc chloride (ZnCl2). Each session comprises three consecutive 10-minute phases with no break between phases, each employing a distinct frequency and mineral salt: Phase 1 – T-regulatory cell focus (LiCl-modulated frequency: ~4.2 Hz) Phase 2 – ß-cell inflammatory pathway focus (MgCl2-modulated frequency: ~5.6 Hz) Phase 3 – Insulin secretion pathway focus (ZnCl2-modulated frequency: ~6.8 Hz) Sessions are administered at the study clinic by trained research staff. The mineral salts are sealed in ampoules within the device’s optical chamber and are not applied to the participant. The infrared output passes through these crystalline modules, delivering modulated frequency information to the abdominal region (pancreatic zone) via a low-intensity infrared beam (approx. 5 cm in diameter). The total intervention duration will be a minimum of 15 days, extendable to 21 days if the participant experiences no adverse effects and agrees to continue. Adherence will be monitored via: Daily attendance logs Standardised session checklist forms completed by staff Pre- and post-session feedback questionnaires No pharmacological substances are introduced into the body; the intervention involves photonic frequency modulation only.
Sponsors
Study design
Eligibility
Inclusion criteria
Aged 10 to 40 years Confirmed diagnosis of Type 1 Diabetes Mellitus for at least 3 years (i.e., greater than or equal to 36 months) On a stable insulin regimen for the past 3 months or longer (either via injection or pump) Able to attend daily 30-minute clinic visits for the full study period Able to provide informed consent (or assent with guardian consent for ages 10–15)
Exclusion criteria
Diagnosis of diabetes other than Type 1 Diabetes (e.g., Type 2, MODY, or secondary diabetes) Use of non-insulin glucose-lowering medications (e.g., GLP-1 agonists, SGLT2 inhibitors) within the last 3 months History of diabetic ketoacidosis in the last 6 months Presence of advanced diabetes complications (e.g., proliferative retinopathy, stage 3+ nephropathy, severe neuropathy) Severe hypoglycaemia unawareness Major medical illness or condition that could interfere with participation (e.g., cancer, immunodeficiency, epilepsy) Pregnancy or breastfeeding Participation in another interventional clinical trial within the past 3 months Inability to comply with daily clinic visits or give informed consent/assent